Actively Recruiting
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
Led by Cullinan Therapeutics Inc. · Updated on 2026-03-19
24
Participants Needed
15
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase 1b, open-label study of CLN-978 administered subcutaneously in patients with Moderate to Severe Systemic Lupus Erythematosus (SLE).
CONDITIONS
Official Title
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of SLE at least 24 weeks before screening and meeting 2019 EULAR / ACR Classification Criteria at screening
- Presence of one or more autoantibodies: positive anti-nuclear antibody (ANA) test (≥1:80), anti-dsDNA above upper limit of normal, or anti-Sm above upper limit of normal
- Active SLE disease with a SLEDAI total score of 6 or higher at screening
- Inadequate response to at least two treatments including oral corticosteroids, antimalarials, conventional immunosuppressants, or biologics; at least one failed treatment must be an immunosuppressive or biologic agent
- Stable dose of corticosteroids and/or antimalarials before day 1 if currently used
- Laboratory parameters at screening: absolute lymphocyte count ≥0.5 x 10^9/L, peripheral B cell count ≥25 cells/µL, absolute neutrophil count ≥1.0 x 10^9/L, hemoglobin ≥8 g/dL, platelet count ≥75 x 10^9/L, estimated glomerular filtration rate ≥30 mL/min/1.73m2, total bilirubin ≤1.5 times upper limit of normal (except Gilbert's Syndrome), AST and ALT ≤2.5 times upper limit of normal
- For Part B: patients treated in Part A without dose-limiting toxicity or discontinuation due to adverse events, meeting eligibility, and at least 90 days since last CLN-978 dose
You will not qualify if you...
- Active inflammatory diseases other than SLE; thyroiditis or secondary Sjogren's syndrome allowed
- High risk for thrombosis
- Rapidly progressive glomerulonephritis or urine protein/creatinine ratio greater than 3 mg/mg (339 mg/mmol)
- Active severe neuropsychiatric or central nervous system manifestations of SLE
- Evidence of hepatitis B, hepatitis C, HIV, Epstein-Barr virus, or cytomegalovirus infection
- History of splenectomy
- Prior treatment with cellular or gene therapy products targeting any antigen
- Use of investigational therapy within 30 days or 5 drug half-lives before day 1
- Use of anti-CD19 or anti-CD20 therapy less than 3 months before day 1
- Use of non-biologic DMARD within 14 days before day 1
- Use of cyclophosphamide within 1 month or biologic immunomodulating therapy within 2 months before day 1
- Live or attenuated vaccine within 28 days before or during screening
- Active, significant bacterial, viral, fungal, mycobacterial, parasitic, or other infections including SARS-CoV-2 within 14 days before day 1
- Active or latent tuberculosis unless previously treated and no current signs
- Any condition that would not be in the patient's best interest or could affect study assessments per investigator or sponsor judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Cullinan Investigative Site
Avondale, Arizona, United States, 85392
Actively Recruiting
2
Cullinan Investigative Site
Tucson, Arizona, United States, 85704
Actively Recruiting
3
Cullinan Investigative Site
Orlando, Florida, United States, 32808
Actively Recruiting
4
Cullinan Investigative Site
Iowa City, Iowa, United States, 52242
Actively Recruiting
5
Cullinan Investigative Site
New York, New York, United States, 10032
Actively Recruiting
6
Cullinan Investigative Site
Rochester, New York, United States, 14642
Actively Recruiting
7
Cullinan Investigative Site
Memphis, Tennessee, United States, 38163
Actively Recruiting
8
Cullinan Investigative Site
Plano, Texas, United States, 75093
Actively Recruiting
9
Cullinan Investigative Site
Webster, Texas, United States, 77598
Actively Recruiting
10
Cullinan Investigative Site
Salt Lake City, Utah, United States, 84101
Actively Recruiting
11
Cullinan Investigative Site
Parkville, Victoria, Australia, 3052
Actively Recruiting
12
Cullinan Investigative Site
Victoria Park, Australia, 6100
Actively Recruiting
13
Arensia Research Clinic
Sofia, Bulgaria
Actively Recruiting
14
Arensia Research Clinic
Tbilisi, Georgia
Actively Recruiting
15
Arensia Research Clinic
Chisinau, Moldova
Actively Recruiting
Research Team
M
Meagan Sardinha
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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